DRISTAN 12 HR- oxymetazoline hydrochloride spray 
Foundation Consumer Brands

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Dristan ®
12 hr

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

Warnings

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

When using this product

  • do not use more than directed
  • do not use for more than 3 days
  • use only as directed
  • frequent or prolonged use may cause nasal congestion to recur or worsen
  • may cause temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge
  • the use of this container by more than one person may spread infection

Stop use and ask a doctor ifsymptoms persist

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium, hypromellose, phosphoric acid, purified water, sodium chloride

Questions or comments?

Call 1-888-594-0710weekdays 9 AM to 5 PM EST

Distributed by:
Foundation Consumer Brands, LLC
Pittsburgh, PA 15212

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

Dristan ®
12
HOUR
NASAL
SPRAY

Oxymetazoline HCl 0.05%
Nasal Decongestant

Fast Acting Relief
Sinus & Nasal
Congestion

Relieves:

0.5 FL OZ (15 mL)

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
DRISTAN  12 HR
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80070-400
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Product Characteristics
Coloryellow (clear, colorless to slightly yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80070-400-051 in 1 CARTON08/17/2021
115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01208/17/2021
Labeler - Foundation Consumer Brands (117603632)

Revised: 11/2024
Document Id: 26576536-79d1-a6fc-e063-6394a90a485f
Set id: 522876fe-a412-4ca8-bfad-a313e3cbc1af
Version: 2
Effective Time: 20241107
 
Foundation Consumer Brands